510(k) K945788 ยท EOB Nasopharyngoscope (Flexible Or Rigid)
KARL STORZ RIGID TELESCOPES FOR ENT ENDOSCOPIC PROCEDURES
| Applicant | KARL STORZ Endoscopy-America, Inc., Culver City CA, US |
| Decision | Substantially Equivalent, Jan 25, 1995 |
| Received | Nov 25, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945788
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2026 | Karl Storz Endoscopy HOPKINS Telescope 30, 4mm REF 10005BA
UDI-DI code: 04048551045121
KARL STORZ HOPKINS and HOPKINS II telescopes are to be used for visualization of the surgical site during diagnostic and therapeutic Open, Classified |
EOB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.